Randomized, Placebo-controlled, Double-blind Study to Evaluate 2LPAPI® Efficacy on the Clearance of Genital HR-HPV Infections.
Human papillomavirus (HPV) is a prevalent pathogen, the epidemiology of which has mostly been studied in the uterine cervix and the vagina. In Belgium, since 2025, HPV testing has become the primary screening method for cervical cancer. For women between 30 and 64 years, a clinical guideline (March 2025) from Sciensano stated the following The triage of HPV-positive women is based on HPV type and reflex cytology outcome as a threshold for colposcopy. In 30- to 64-year-olds, triage of HR-HPV non-16/18 positives consists of an initial reflex cytology, followed by another HPV test 12 months later if the first step demonstrated Negative for Intraepithelial Lesion or Malignancy (NILM). Women who test positive on the initial HR-HPV test for the most high-risk HPV types 16 or 18 are immediately referred for colposcopy. Besides colposcopy, a reflex cytology will be performed. . Women from 25 to 29 years are recommended to undergo a cytology testing on cervical smear as primary screening method following Sciensano clinical guideline (March 2025) recommendations. If abnormalities are detected, a HPV testing is performed. For the two age groups, if low grade abnormalities are detected with a diagnosis of HR-HPV, a second triage is recommended at 12 months. There is no treatment that is recommended during this lap time. The 2LPAPI® has been available for more than 20 years, and has received a marketing authorization in Belgium by the FAMHP. It is used as an immune regulator in the treatment of HR-HPV infections. Since 2LPAPI® has been made available, clinical observational data collected on treated patients have shown the beneficial effect on the clearance of HPV. The purpose of this placebo-controlled trial is to evaluate the efficacy of 2LPAPI® on the clearance of genital HR-HPV infections.
• Women 25-45 years,
• Women of childbearing age under effective contraception,
• Patient with last cytology less than 3 years and normal or not more than LSIL or CIN I at the histology,
• Patient with current cytology presenting normal, ASC-US, AGUS, LSIL, ASC-H, AGC or LSIL+ASC-H results or current diagnosis of CIN I at the histology,
• Patient with HR-HPV diagnosis at the current cervical collection,
• Patient reporting a current stable sexual relationship (steady sexual partner during study duration),
• Patient having faculties to understand and respect the constraints of the study,
• Signature of the Informed Consent Form.